Topical composition

Details Topical composition Topical composition

1995-02-08

2001-04-24

Pak, John (Department: 1616)

Drug, bio-affecting and body treating compositions

Inorganic active ingredient containing

Heavy metal or compound thereof

C424S641000, C424S647000, C424S648000, C424S402000, C424S404000, C424S443000, C424S444000, C424S445000, C424S446000, C424S447000, C424S449000, C424SDIG001, C424S485000, C424S488000, C514S777000, C514S780000, C514S782000, C514S785000, C514S786000, C514S789000, C514S827000, C514S828000, C514S829000, C514S830000, C514S848000, C514S859000

Reexamination Certificate

active

06221403

ABSTRACT:

This invention relates to a topical composition comprising zinc. oxide particularly, but not exclusively for impregnating a bandage.
Bandages impregnated with pastes containing zinc oxide are commonly used for the treatment of skin complaints such as leg ulcers, varicose eczemas and chronic determatitis. These known pastes are not sufficiently emulsified and are therefore unstable, particularly when subjected to sterilisation processes such as heating and irradiation. As these known pastes cannot be properly sterilised it is conventional to include “preservatives” which include antibacterial and antiviral agents, such as alkyl p-hydroxybenzoates, in order to irradicate any bacteria or viruses that are not removed by sterilisation. These preservatives cause hyposensitivity when the bandage comprising the paste is applied to the wound.
The present invention has been made from a consideration of this problem.
According to the present, invention there is provided a topical composition for impregnating a bandage comprising zinc oxide in a stable emulsion comprising at least one fat and/or oil, at least one emulsifying agent, at least one water soluble viscosity improver and water in the absence of a preservative.
The stable emulsions of the compositions of the present invention eliminate the need for a preservative. Thus topical zinc oxide containing compositions can be made which do not suffer from the drawback of sensitivity.
The compositions of the invention are primarily intended for impregnating bandages for use in the treatment of skin diseases.
The zinc oxide is the active agent. The composition preferably comprises from 0.5% to 40.0% wt of zinc oxide and more preferably substantially 15% wt of zinc oxide. The composition may comprise additional active ingredients such as calamine, icthammol, clioquinol and coal tar. The composition preferably comprises from 0 to 40% wt of additional actives.
In a preferred embodiment of the invention the fats and/or oils comprise fractionated coconut oil and/or synthetic spermaceti, combinations of cetyl alcohol; stearyl alcohol; other alcohols (C
8
to C
24
); triglyceride oils or fats; esters such as cetyl palmitate, myristyl myristate; liquid and solid paraffins or other commonly used cosmetic fats and oils The fats and/or oil form an oil in water emulsion. The composition preferably comprises from 0.2 to 45% wt fat and/or oil and more preferably from 2 to 16% wt fat and/or oil.
The emulsifying agent is preferably polyethoxylated. Preferred examples include tween 80 polysorbate 20, 21, 40, 60, 61, 65, 81, 85, 120 and other polyoxyethylene adducts of sorbitan esters; fatty acids; fatty alcohols; lanolin; lanolin alcohols; castor oil (natural or hydrogenated) or alkylbenzenes. The emulsifying agent has a high HLB and emulsifies the fat and/or oils into the oil in water emulsion. The composition preferably comprises from 0.3 to 10% wt and still more preferably from 0.5% to 2% wt of emulsifying agent.
The water soluble viscosity improver increases the viscosity of the aqueous phase for stabilisation. One preferred material is xantham gum. The composition preferably comprises from 0.5 to 4.0% of viscosity improver and more preferably from 0.05 to 1.2%.
In a preferred embodiment of the invention the compositions preferably comprise the following ingredients either alone or in combination: at least one low HLB emulsifying agent to emulsify the fats and/or oils, at least one inorganic suspending agent in order to suspend the zinc oxide and improve the stability of the composition and glycerol which acts as a humectant in order to improve the water retention of the composition and to provide emollient properties to the skin.


REFERENCES:
patent: 3803300 (1974-04-01), Pospischil
patent: 4512978 (1985-04-01), Inwood
patent: 4678664 (1987-07-01), Schmolka
patent: 4816254 (1989-03-01), Moss
patent: 4909243 (1990-03-01), Frank et al.
patent: 5948416 (1999-09-01), Wagner et al.
patent: 1128170 (1968-09-01), None
patent: 2233227A (1991-01-01), None
patent: 57-171907 (1982-10-01), None
Remington's Pharmaceutical Sciences, 18th ed., Mack Printing Co., PA, 1990, pp. 762-763, 1602-1604, 1613, 1990.*
Derwent Abstract Accession No. 82-03408J, abstracting JP 57-171907, Oct. 22, 1982.

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